MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TEMP PUMP TEMPERATURE; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number TP500

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 07/08/2015

Event Type  Injury  

Event Description

It was reported that allegedly the patient had redness and small clear blisters on left side of abdomen after sleeping with heating pad overnight.Medical intervention was not reported.

Manufacturer Narrative

A visual and functional inspection was allegedly performed by the biomed technician at the user facility.The alleged inspection found that the unit had no malfunctions and the unit was working properly to specifications.It was reported that the patient allegedly had redness of the skin as well as small clear blisters after receiving treatment from the tp500 unit.The skin irritation was confirmed by a medical professional at the customer location which reported that the irritation was likely a pressure ulcer as the patient was not being regularly turned and/or checked by a caregiver.The patient complained of discomfort which is how the pressure ulcers were identified.It was reported that the patient did require additional medical intervention, further information on the type of medical intervention was not reported.User facility evaluated the device.

Event Description

It was reported that allegedly the patient had redness and small clear blisters on left side of abdomen after sleeping with heating pad overnight.Medical intervention was reported.

• Brand Name: TEMP PUMP TEMPERATURE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4972975
• MDR Text Key: 23603373
• Report Number: 0001831750-2015-00385
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: TP500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1